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Enlivex Receives Regulatory Authorization From Israel s Health Ministry For The Initiation Of Phase 1/2 Trial Evaluating Allocetra In Patients With Knee Osteoarthritis

For some, the cause of this debilitating knee pain that can cause mobility issues is osteoarthritis in the knee, which makes it painful to jog, run, climb stairs or kneel. Over time, osteoarthritis of the knee symptoms can become more drastic, changing the shape of patients' knees and making their joints feel wobbly.

Treatment can include surgery, but most healthcare providers attempt non-surgical treatments like physical therapy, knee braces and pain medications before recommending surgery. A new cell therapy could provide patients with another option.

In January, the Israeli Ministry of Health (IMOH) authorized the initiation of a new trial for Allocetra^TM, a groundbreaking cell therapy that could help treat osteoarthritis patients.

Sponsored by clinical-stage macrophage reprogramming immunotherapy company Enlivex Therapeutics Ltd. (NASDAQ:ENLV), the multi-country, double-blind, randomized, placebo-controlled phase 1/2 trial will evaluate the efficacy, safety and tolerability of Allocetra following injections into the target knee joint of up to 160 moderately to severely symptomatic osteoarthritis patients.

Approximately 46% of people will develop osteoarthritis of the knee during their lifetimes. The condition occurs when the cartilage in your knee joint breaks down. This causes the bones to rub together - friction that causes knee pain, swelling and stiffness. There is no cure for osteoarthritis in the knee, but there are treatments to slow its progress and ease symptoms.

Allocetra is a universal, off-the-shelf cell therapy built to reprogram macrophages into their homeostatic state. Diseases such as osteoarthritis, sepsis and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases.

By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening and debilitating clinical indications. With the recent understanding that osteoarthritis is a low-grade inflammatory chronic condition derived by macrophages, these cells are now emerging targets in osteoarthritis treatment. Allocetra injection into the knee may lead to disease resolution by rebalancing the immune microenvironment through the reprogramming of non-homeostatic macrophages .

Following the enrollment progress of knee osteoarthritis end-stage patients in a phase 1/2 investigator-initiated clinical trial, Enlivex's upcoming work will expand the osteoarthritis vertical to include moderate and severe osteoarthritis patients. This patient population comprises the majority segment of those who suffer from knee osteoarthritis.

The phase 1/2 multi-center trial will be completed in two stages. The first stage will be a safety run-in, open-label dose escalation phase to characterize the safety and tolerability of Allocetra injections to the target knee. This will help doctors identify the dose and injection regimen for the randomized stage.

The second stage will be a double-blind, randomized placebo-controlled stage, expected to launch following the completion of the safety run-in stage and confirmation by the safety and tolerability independent Data Safety Monitoring Board. On top of evaluating the safety, the blinded randomized stage will be statistically powered to assess the efficacy of Allocetra injections into the knee. The primary measurements will be comparisons of joint pain and joint function compared to placebo at three months, six months and 12 months.

"Macrophages are now considered as an emerging therapeutic target in the treatment of osteoarthritis," said Einat Galamidi, M.D., Vice President, Medical of Enlivex. "The macrophage reprogramming mechanism of action of Allocetra positions it as a potentially promising therapy for this substantial unmet life-debilitating indication."

"As announced in September 2023, we are increasing our focus on inflammatory diseases and specifically pushing forward the osteoarthritis development program," added Oren Hershkovitz, Ph.D., CEO of Enlivex. "The iMOH approval is an important operational milestone enabling us to continue the evaluation of Allocetra safety and efficacy in knee osteoarthritis patients in a statistically-powered, blinded, randomized controlled study."

Featured photo by Anna on Unsplash.

Contact:

Shachar Shlosberger
shachar@enlivexpharm.com

SOURCE: Enlivex Therapeutics Ltd.